Comparison of Latanoprost Vs. Timolol

08:23 EDT 23rd October 2014 | BioPortfolio

Summary

The primary purpose of this study is to show, through a controlled masked clinical study of subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral drainage of aqueous humor back to normal levels, and timolol maleate reduces the formation of aqueous humor below normal. Both of these mechanisms will effectively reduce intraocular pressure (IOP).

The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility, and episcleral venous pressure and on all parameters over time.

Description

A recent publication by our laboratory has shown that patients with ocular hypertension (OHT) have reduced uveoscleral outflow and reduced trabecular outflow facility compared with healthy age-matched controls. These changes are the cause of the elevated intraocular pressure (IOP). Aqueous flow rate did not change in these patients. It is logical to assume that it would be more efficacious to treat OHT patients with drugs that reduce IOP by increasing uveoscleral outflow (which is abnormally low) than with drugs that reduce aqueous flow (which is normal in OHT).

The primary purpose of this study is to show, through a controlled masked clinical study of OHT patients, that latanoprost increases the low uveoscleral drainage of aqueous humor (Fu) back to normal levels, and timolol maleate reduces the formation of aqueous humor (Fa) below normal. Both of these mechanisms will effectively reduce IOP.

The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility (Cflu), and episcleral venous pressure (Pev) and on all parameters over time.

Subjects eligible to participate will be at least 19 years of age and diagnosed with bilateral ocular hypertension or primary open angle glaucoma and have intraocular pressure between 20 and 35 mmHg in both eyes on Day 0. Subjects will be treated with either latanoprost or timolol for 6 weeks and then crossover and be treated similarly with the alternate drug for an additional 6 weeks. There will be a screening visit and a total of 6 study visits in which aqueous humor flow, uveoscleral outflow, and fluorophotometric outflow facility will be determined using an instrument called a fluorophotometer. The fluorophotometer scans the eye for fluorescein dye allowing the investigator to measure and calculate the above variables. There will be 7 scans taken during each study day and additionally IOP will be measured after the completion of each scan. An Exit exam will be performed at the time of exit to ensure the ocular health of the subject.

Subjects will be monitored for adverse events throughout the course of the study and subjects may discontinue from the study at any time for any reason, or may be discontinued if, in the opinion of the investigator, there is a risk to the subject.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Glaucoma

Intervention

Latanoprost, Timolol

Location

UNMC Department of Ophthalmolgy and Visual Sciences
Omaha
Nebraska
United States
68198-5540

Status

Completed

Source

University of Nebraska

Results (where available)

View Results

Links

Clinical Trials [103 Associated Clinical Trials listed on BioPortfolio]

A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.

24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, vers...

Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (bimatoprost and timolol) for chr...

24-hour Intraocular Pressure (IOP) Control With Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combination in Open-angle Glaucoma

The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twi...

A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

PubMed Articles [23 Associated PubMed Articles listed on BioPortfolio]

The Efficacy of a Latanoprost/Timolol Fixed Combination Versus Latanoprost and Timolol Gel-forming Solution Unfixed Combination on Daytime Intraocular Pressure.

To evaluate the effect of a latanoprost/timolol fixed combination (LTFC) versus a latanoprost and timolol gel-forming solution unfixed combination (LTuFC) on daytime intraocular pressure (IOP) levels ...

Diurnal Intraocular Pressure with Bimatoprost/Timolol Fixed Combination versus Latanoprost/Timolol Fixed Combination in Healthy Subjects.

To evaluate the effects of a bimatoprost/timolol fixed combination (BTFC) and a latanoprost/timolol fixed combination (LTFC) on diurnal intraocular pressure (IOP) and anterior ocular parameters in hea...

Comparing the Efficacy of Latanoprost (0.005%), Bimatoprost (0.03%), Travoprost (0.004%), and Timolol (0.5%) in the Treatment of Primary Open Angle Glaucoma.

To compare the efficacy and safety of latanoprost, bimatoprost, travoprost and timolol in reducing intraocular pressure (IOP) in patients with primary open angle glaucoma.

Bimatoprost/timolol fixed combination versus latanoprost in treatment-naïve glaucoma patients at high risk of progression: a pilot study.

To compare a fixed combination of 0.03% bimatoprost and 0.5% timolol (BTFC) with latanoprost monotherapy (LM) in treatment-naïve patients with open-angle glaucoma (OAG) and risk factors for glaucomat...

Preservative Substances - the Daily Dose of Benzalkonium Chloride in Glaucoma Treatment from the Patients Point of View.

The author calculated the daily dose of Benzalkonium Chloride (BAC) in eye drops used in glaucoma treatment from the patients point of view, which means the real amount of BAC applied in the conjuncti...

Medical and Biotech [MESH] Definitions

A beta-adrenergic antagonist similar in action to PROPRANOLOL. The levo-isomer is the more active. Timolol has been proposed as an antihypertensive, antiarrhythmic, antiangina, and antiglaucoma agent. It is also used in the treatment of MIGRAINE DISORDERS and tremor.

A localized defect in the visual field bordered by an area of normal vision. This occurs with a variety of EYE DISEASES (e.g., RETINAL DISEASES and GLAUCOMA); OPTIC NERVE DISEASES, and other conditions.

A form of GLAUCOMA in which chronic optic nerve damage and loss of vision normally attributable to buildup of intraocular pressure occurs despite prevailing conditions of normal intraocular pressure.

Rare congenital disorder of connective tissue characterized by brachydactyly, joint stiffness, childhood onset of ocular abnormalities (e.g., microspherophakia, ECTOPIA LENTIS; GLAUCOMA), and proportionate short stature. Cardiovascular anomalies are occasionally seen.

A technique of diagnostic imaging of RETINA or CORNEA of the human eye involving the measurement and interpretation of polarizing ELECTROMAGNETIC WAVES such as radio or light waves. It is helpful in the diagnosis of GLAUCOMA; MACULAR DEGENERATION; and other retinal disorders.

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